With more and more people's change on the concept of beauty, and the increasing standards in their personal health, body shape, and weight, weight loss and body contouring are no longer issues cared only by obese individuals. Therefore, weight loss and fitness center and weight management market are booming, driving relative developments such as, diet foods, fitness products, weight loss clinical management, medical equipment, fitness equipment, etc. According to the statistic report “Global Weight Loss and Gain Market 2009-2014” issued by Marketsand Markets, the global weight management market was estimated to be US $586.3 billion in 2014 and could grow into $650.9 billion in 2015; wherein the primary market is the United States, it's market scale was estimated to reach $310 billion, and the estimated market scale of Europe, the second largest market, is $238 billion. At the same time, due to the rise of consumer's concern of the awareness on health, especially on the after effects of chronic diseases caused by obesity, has made it an increasingly important agenda globally; therefore, besides targeting the obesity population, more and more people are actively developing on body weight control and body contouring for the healthy population, which has drawn strong attentions of all industries towards the body weight control and body contouring and led to the development boom in the industry, the above-mentioned reasons are all the main reasons why the market could grow steadily. The statistics of American Society of Plastic Surgeons (ASPS) issued in 2012 showed that the demand of body contouring has continuously ranked first in the field of plastic surgery and estimated demands would maintain an annual growth rate at about 12.3% until 2017. “Global Pipeline Analysis, Competitive Landscape and Market Forecasts” published by Research and Markets showed that global market of body contouring equipment reached $900 million in 2010 and estimated to increase into $2 billion in 2017. It is because the demand of the body contouring market is huge and keeps on growing every year, various ways of liposuction and lipolytic methods appear on the market. In contrast, many high-risk or unsafe medical treatments have also appeared one after another.
Conventional liposuction surgery was developed as early as in the 1970s; because of the way of liposuction by dry liposuction under negative pressure without any infusion solution, the subcutaneous nerves and blood vessels were damaged greatly; moreover, the amount of blood loss was large and the risk of surgery was high. Tumescent liposuction and super wet liposuction were developed later on. Tumescent liposuction is by adding anesthetic and vasoconstrictor into the infusion solution, even though, in this method, local anesthesia replaces intravenous anesthesia, large amount of infusion solution has caused the anesthetic requires at least 12 hours to be metabolized, and hence increased the possible risks of local anesthetic to human body. Recently, the method which doctors preferably choose to use on large amount of liposuction is super wet liposuction, its characteristic is that the volume exchange of infusion solution has to be equal to the extracted fat and the chance of overload infusion can be effectively reduced. However, clinically, there are limitations to the sites of administration, the sites are primarily the areas with large fat accumulation such as the abdomen, and the thighs etc; meanwhile, the efficacy and safety of liposuction depend entirely on the skill and the proficiency of the surgeon. The process of liposuction cause much harm to the body, time-consuming, and would still causes side effects such as, severe postoperative bruising, swelling, pain and sensory paralysis, scar tissue, unsmooth skin surface; the recovery period could range from four to six weeks. Due to the lengthy operation time of liposuction, the greater blood loss has directly increased its surgical risk. Therefore, various auxiliary liposuction instruments are being designed by every industry, and thus auxiliary methods of liposuction like ultrasound and laser were developed one after another, the key factor is still the skill of the performing surgeon. Furthermore, cases of tissue burn or poor efficacy occur frequently while using relative auxiliary liposuction instruments. In view of the drawback faced in liposuction, every industry was continuously making improvements in both technique and instrument; the aesthetic medical industry of the United States and Europe are focusing on the development of aesthetic medical equipment since the 1980s. In the field of body weight control and body contouring, the manufacturers have transformed their main appeal from traditional liposuction to minimally invasive and even non-invasive lipolysis instrument. The goals of lipolytic products or instruments are to improve the traditional faults of large blood loss, lengthy recovery period, postoperative scars, and try to be less invasive, high safety, convenient, smaller wound, and short recovery period as possible; at the same time, maintain the advantages of better efficacy and competitive price for it to enter the aesthetic medical market with the enough advantages.
There is a lipolytic method by using mesotherapy, which uses phosphatidylcholine or sodium deoxycholate as active ingredients to inject to the obese region to lyse fat. The structure of this kind of ingredients is similar to the ingredient of cell membrane; therefore, it could break down the cell membrane of adipocyte cells and trigger cell necrosis. Injecting this kind of medicine into the mesoderm would cause massive adipocyte cell necrosis and then cause fat release; due to the medicine does not possess specificity, namely, not only targeted on adipocytes, many normal surrounding cells would also be affected and thus cause necrosis, in addition, cell necrosis would cause the surrounding tissue to initiate a series of inflammation reaction, further causing administration site inflammation, severe pain, and swelling, and even causing the risks of local tissue necrosis or infection. Although lipolytic method by injection, comparing to using large liposuction instrument, could overcomes the limitation in administration site, one lipolysis injection treatment course may require several dozens of injections every 2 weeks and 1 to 6 treatment course(s) to reach the goal of lipolysis effect. Although anesthetic has been added to the injection solution, the injected site may still suffer from severe inflammation and pain after the anesthesia has subsided, in addition, the number of treatment and injection frequency also needs to be improved. Consider of the risks of severe postoperative pain, nerve paralysis, local tissue necrosis, or infections, the limited dosage in single injection, and restricted to be applied in face, most surgeons no longer inject the ingredients mentioned above to reduce localized fat of the patient; although the United States has approved the first lipolysis inject product made from sodium deoxycholate, it has a certain degree of side-effects and could only use in double chin, making its usage to be limited. Overall, a product that could effectively reduce localized fat, has lower side effects, safer is lacking on the current market; therefore, under the high demand of surgeons and consumers, it is a trend in the market to develop a localized lipolysis injection formulation that is safer, with low side effects, and could overcome the mentioned defects and limitations.